A multicentre, randomised controlled trial to compare the clinical and cost-effectiveness of Lee Silverman Voice Treatment versus standard NHS Speech and Language Therapy versus control in Parkinson’s disease: a study protocol for a randomised controlled trial

Trials

on behalf of the PD COMM Collaborative Group¹  P. Masterson-Algar²  M. Caulfield²  R. Woolley³  P. Au³  M. Hughes³  N. Ives³  S. Patel³  F. Dowling⁴  C. H. Smith⁵  S. Jowett⁶  C. E. Clarke⁷  S. Dickson⁸  M. C. Brady⁸  A. Nicoll⁸  C. Rick⁹  C. M. Sackley^1,10  G. Beaton^1,11  C. Burton^1,12 

[1] ;Bangor Institute for Health and Medical Research, School of Healthcare Sciences, Bangor University;Birmingham Clinical Trials Unit, University of Birmingham;Cambridge Clinical Trials Unit, Cambridge University Hospitals NHS Foundation Trust;Division of Psychology and Language Science, Faculty of Brain Sciences, University College London;Health Economics, University of Birmingham;Institute for Applied Health Research, University of Birmingham;NMAHP Research Unit, Glasgow Caledonian University;Nottingham Clinical Trials Unit, University of Nottingham;Population Health Sciences, Addison House, King’s College London;Queen Elizabeth Hospital, NHS Greater Glasgow and Clyde;School of Allied and Public Health Professions, Canterbury Christ church University;

关键词: Idiopathic Parkinson’s disease;    Lee Silverman voice treatment;    Speech and language therapy;    Randomised controlled trial;    Dysarthria;   

DOI  :  10.1186/s13063-020-04354-7

来源: DOAJ

【 摘 要 】

Abstract Background Parkinson’s disease (PD) affects approximately 145,519 people in the UK. Speech impairments are common with a reported prevalence of 68%, which increase physical and mental demands during conversation, reliance on family and/or carers, and the likelihood of social withdrawal reducing quality of life. In the UK, two approaches to Speech and Language Therapy (SLT) intervention are commonly available: National Health Service (NHS) SLT or Lee Silverman Voice Treatment (LSVT LOUD®). NHS SLT is tailored to the individuals’ needs per local practice typically consisting of six to eight weekly sessions; LSVT LOUD® comprises 16 sessions of individual treatment with home-based practice over 4 weeks. The evidence-base for their effectiveness is inconclusive. Methods/design PD COMM is a phase III, multicentre, three-arm, unblinded, randomised controlled trial. Five hundred and forty-six people with idiopathic PD, reporting speech or voice problems will be enrolled. We will exclude those with a diagnosis of dementia, laryngeal pathology or those who have received SLT for speech problems in the previous 2 years. Following informed consent and completion of baseline assessments, participants will be randomised in a 1:1:1 ratio to no-intervention control, NHS SLT or LSVT LOUD® via a central computer-generated programme, using a minimisation procedure with a random element, to ensure allocation concealment. Participants randomised to the intervention groups will start treatment within 4 (NHS SLT) or 7 (LSVT LOUD®) weeks of randomisation. Primary outcome: Voice Handicap Index (VHI) total score at 3 months. Secondary outcomes include: VHI subscales, Parkinson’s Disease Questionnaire-39; Questionnaire on Acquired Speech Disorders; EuroQol-5D-5 L; ICECAP-O; resource utilisation; adverse events and carer quality of life. Mixed-methods process and health economic evaluations will take place alongside the trial. Assessments will be completed before randomisation and at 3, 6 and 12 months after randomisation. The trial started in December 2015 and will run for 77 months. Recruitment will take place in approximately 42 sites around the UK. Discussion The trial will test the hypothesis that SLT is effective for the treatment of speech or voice problems in people with PD compared to no SLT. It will further test whether NHS SLT or LSVT LOUD® provide greater benefit and determine the cost-effectiveness of both interventions. Trial registration International Standard Randomised Controlled Trials Number (ISRCTN) Registry, ID: 12421382 . Registered on 18 April 2016.

【 授权许可】

Unknown